MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 6X40; STENT, CAROTID

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2020

Event Type  malfunction  

Manufacturer Narrative

The stent of a precise pro rx 6mm x 40mm nitinol stent system could not fit tightly to the deployment sheath when the pc stent was in the spiral tray, the part which holds the sds inside the packaging.The stent was exposed outside of the deployment sheath.The tip of the deployment sheath could not dock into the delivery shaft; the stent was not contained in the sheath introducer.The procedure was completed with another unknown stent.The procedure was a carotid artery stenting (cas) at the bifurcation of the carotid artery.The access site was the femoral artery.The device was prepped per the instructions for use (ifu) and there was difficulty prepping the device.The guidewire port was flushed as outlined in the ifu prior to loading on the guidewire.An unknown 8f sheath was used.There was no reported patient injury.The product was returned for analysis.One non-sterile precise pro rx 6x40 stent delivery system was received for analysis inside a plastic bag.The mentioned spiral tray associated to this complaint (as referred in the description summary of the complaint) was not returned for evaluation.The valve of the precise pro rx was received closed.Per visual analysis, the stent of the unit was received 0.4 cm premature deployed.Traces of dried blood residues were observed.Also, the hypo tube of the unit was observed lightly bent.Besides the afore mentioned conditions, no obvious defects or anomalies were found that could had contributed to the reported event.Per functional analysis, a deployment test was performed on the unit.The tuohy borst valve of the stent delivery system was opened, and the stent deployment test was successfully performed by retracting the outer sheath while holding the inner shaft in a fixed position.The stent was fully unsheathed/expanded as expected.No anomalies found.Per dimensional analysis, the usable length of the unit was measured and was found within specification.A product history record (phr) review of lot 17928283 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses-deployment difficulty - premature/during prep¿ was confirmed since the stent of the unit was received for analysis 0.4 cm pre deployed.However, the exact cause of the stent delivery system pre deployment condition could not be conclusively determined during the analysis.Although the stent was received 0.4 cm pre deployed, the device seems to have been procedurally used since the valve of the precise pro rx was received closed ( per the ifu, precise pro rx nitinol stent systems are shipped with the hemovalve in the open position.) additionally, the hypo tube was observed lightly bent on the catheters¿ outer member and traces of dried blood was noted on the product during visual analysis.It can be suggested that procedural ( traces of dried blood residues) and or handling process such as the user interaction with the device may have contributed to the stent pre deployment condition of the unit as received.Analysis results and phr review results do not suggest that the observed pre-deployment condition is related to the manufacturing process.According to the instructions for use ¿preparation of stent delivery system caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.Extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.Ensure that the tuohy borst valve connecting the inner shaft and outer sheath is locked by rotating the proximal valve end in a clockwise direction to prevent premature stent deployment¿.Neither the product analysis nor the phr review suggests that the event experienced by the customer is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, the stent of 6x40 precise pro rx nitinol stent system could not fit tightly to the deployment sheath when the pc stent was in the spiral tray, the part which holds the sds inside the packaging.The stent was exposed outside of the deployment sheath.The tip of the deployment sheath could not dock into the delivery shaft; the stent was not contained in the sheath introducer.The procedure was completed with another unknown stent.There was no reported patient injury.The procedure was a carotid artery stenting (cas) at the bifurcation of the carotid artery.The access site was the femoral artery.The device was prepped per the instructions for use (ifu) and there was difficulty prepping the device.The guidewire port was flushed as outlined in the ifu prior to loading on the guidewire.An unknown 8f sheath was used.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.

• Brand Name: PRECISE PRO RX 6X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10705369
• MDR Text Key: 212145005
• Report Number: 9616099-2020-03997
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: PC0640XCE
• Device Lot Number: 17928283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 8F SHEATH